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Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE.

Publication ,  Journal Article
Alexander, BM; Ba, S; Berger, MS; Berry, DA; Cavenee, WK; Chang, SM; Cloughesy, TF; Jiang, T; Khasraw, M; Li, W; Mittman, R; Poste, GH ...
Published in: Clin Cancer Res
February 15, 2018

Glioblastoma (GBM) is a deadly disease with few effective therapies. Although much has been learned about the molecular characteristics of the disease, this knowledge has not been translated into clinical improvements for patients. At the same time, many new therapies are being developed. Many of these therapies have potential biomarkers to identify responders. The result is an enormous amount of testable clinical questions that must be answered efficiently. The GBM Adaptive Global Innovative Learning Environment (GBM AGILE) is a novel, multi-arm, platform trial designed to address these challenges. It is the result of the collective work of over 130 oncologists, statisticians, pathologists, neurosurgeons, imagers, and translational and basic scientists from around the world. GBM AGILE is composed of two stages. The first stage is a Bayesian adaptively randomized screening stage to identify effective therapies based on impact on overall survival compared with a common control. This stage also finds the population in which the therapy shows the most promise based on clinical indication and biomarker status. Highly effective therapies transition in an inferentially seamless manner in the identified population to a second confirmatory stage. The second stage uses fixed randomization to confirm the findings from the first stage to support registration. Therapeutic arms with biomarkers may be added to the trial over time, while others complete testing. The design of GBM AGILE enables rapid clinical testing of new therapies and biomarkers to speed highly effective therapies to clinical practice. Clin Cancer Res; 24(4); 737-43. ©2017 AACR.

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Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

February 15, 2018

Volume

24

Issue

4

Start / End Page

737 / 743

Location

United States

Related Subject Headings

  • Survival Analysis
  • Research Design
  • Randomized Controlled Trials as Topic
  • Oncology & Carcinogenesis
  • Humans
  • Glioblastoma
  • Clinical Trials, Phase III as Topic
  • Clinical Trials, Phase II as Topic
  • Brain Neoplasms
  • Biomarkers, Tumor
 

Citation

APA
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MLA
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Alexander, B. M., Ba, S., Berger, M. S., Berry, D. A., Cavenee, W. K., Chang, S. M., … GBM AGILE Network, . (2018). Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE. Clin Cancer Res, 24(4), 737–743. https://doi.org/10.1158/1078-0432.CCR-17-0764
Alexander, Brian M., Sujuan Ba, Mitchel S. Berger, Donald A. Berry, Webster K. Cavenee, Susan M. Chang, Timothy F. Cloughesy, et al. “Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE.Clin Cancer Res 24, no. 4 (February 15, 2018): 737–43. https://doi.org/10.1158/1078-0432.CCR-17-0764.
Alexander BM, Ba S, Berger MS, Berry DA, Cavenee WK, Chang SM, et al. Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE. Clin Cancer Res. 2018 Feb 15;24(4):737–43.
Alexander, Brian M., et al. “Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE.Clin Cancer Res, vol. 24, no. 4, Feb. 2018, pp. 737–43. Pubmed, doi:10.1158/1078-0432.CCR-17-0764.
Alexander BM, Ba S, Berger MS, Berry DA, Cavenee WK, Chang SM, Cloughesy TF, Jiang T, Khasraw M, Li W, Mittman R, Poste GH, Wen PY, Yung WKA, Barker AD, GBM AGILE Network. Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE. Clin Cancer Res. 2018 Feb 15;24(4):737–743.

Published In

Clin Cancer Res

DOI

EISSN

1557-3265

Publication Date

February 15, 2018

Volume

24

Issue

4

Start / End Page

737 / 743

Location

United States

Related Subject Headings

  • Survival Analysis
  • Research Design
  • Randomized Controlled Trials as Topic
  • Oncology & Carcinogenesis
  • Humans
  • Glioblastoma
  • Clinical Trials, Phase III as Topic
  • Clinical Trials, Phase II as Topic
  • Brain Neoplasms
  • Biomarkers, Tumor